• Sr Business Analyst, Manufacturing

    Cordis (Irvine, CA)
    …implement practical business solutions under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation ... user stories, and test scripts; proficient with SQL for data validation . + Excellent facilitation, communication, and stakeholder-management skills. + Motivated to… more
    Cordis (07/30/25)
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  • Computer Systems Validation…

    Unither Pharmaceuticals (Rochester, NY)
    Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
    Unither Pharmaceuticals (08/27/25)
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  • Senior Computer Systems Validation…

    Catalent Pharma Solutions (Harmans, MD)
    **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... is hiring a Senior Engineer, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and… more
    Catalent Pharma Solutions (08/08/25)
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  • Computer System Validation Engineer

    Abeona (Cleveland, OH)
    Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System ... laboratory, manufacturing, quality) are validated and maintained in compliance with FDA , EMA, and other global regulatory standards. This role involves close… more
    Abeona (08/11/25)
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  • Senior Validation Specialist-…

    Regeneron Pharmaceuticals (Cambridge, MA)
    …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… more
    Regeneron Pharmaceuticals (07/26/25)
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  • Supervisor, Validation

    Novo Nordisk (Bloomington, IN)
    …: + Develop qualification strategies and documents for novel systems and products + Computer System Validation : + Competent in multiple system types + Mastery of ... 8 AM - 5 PM Relationships Reports to Manager, Validation Essential Functions + Equipment Validation : +...and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry… more
    Novo Nordisk (08/14/25)
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  • Principal Engineer, Validation

    Novo Nordisk (Bloomington, IN)
    …and approve deviations relevant to equipment validation + Understand other validation technical disciplines, such as cleaning, computer system validation ... and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry...other validation technical disciplines, such as equipment validation , computer system validation , and… more
    Novo Nordisk (08/13/25)
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  • Validation Lead(ALM) : QA Life…

    Cognizant (Boston, MA)
    …and 2+ years in a management role. CSV/CSA Expertise: In-depth knowledge of Computer System Validation (CSV) and Computer Software Assurance (CSA) ... ** Validation Lead(ALM) : QA Life Sciences(Hybrid)** Cognizant Technology...ALM Test management tool Regulatory Knowledge: Strong understanding of FDA , EMA, GxP, and 21 CFR Part 11 requirements;… more
    Cognizant (08/27/25)
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  • Associate Validation Specialist

    Catalent Pharma Solutions (Winchester, KY)
    **Associate Validation Specialist** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission ... manufacturing, and roots in industry-leading Glatt technology. The Associate Validation Specialist position shall provide support for cleaning validation… more
    Catalent Pharma Solutions (08/23/25)
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  • Specialist, QA Validation

    Astellas Pharma (Sanford, NC)
    …coverage and flexibility may be required. **Preferred Qualifications** + Experience with computer verification/ validation . + Experience working in a clinical and ... **Specialist, QA Validation ** Do you want to be part of...Assist in the preparation and hosting of regulatory (eg FDA , EMA, DHHS, etc.) inspections as needed. **Required Qualifications**… more
    Astellas Pharma (06/06/25)
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